FDA nixes approval of Avastin for breast cancer

The Food and Drug Administration has revoked Avastin as treatment for breast cancer, citing evidence that the controversial drug carries serious side-effects without offering demonstrable benefits.

Nearly four years after the FDA approved the drug for breast cancer patients, Commissioner Margaret Hamburg said new research doesn’t show Avastin significantly improving their situations and instead increases risk of high blood pressure, hemorrhaging and other serious side effects.

“After reviewing the available studies, it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks,” Ms. Hamburg said. “Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

Ms. Hamburg took five months to release her decision, after holding a two-day hearing in June at the request of Avastin manufacturer Genentech.

Avastin’s risks include severe high blood pressure, bleeding and hemorrhaging, heart attack or heart failure and perforations that can develop in different parts of the body such as the nose, stomach, and intestines, according to the FDA.

Still, many breast cancer patients claim it’s keeping them alive. The FDA approved the drug in 2008 through an accelerates process, basing the decision on a study showing that Avastin seemed to delay tumor growth or death.

Now, Avastin will remain licensed for treatment of colon cancer and other tumors, but some fear that insurers will no longer cover it, making the $88,000 drug difficult for women to obtain.

Elizabeth Thompson, president of the Susan G. Komen Foundation, said the organization would work to make sure women can continue to use Avastin.

“We know that this decision was a difficult one for the FDA and respect the length of time they spent deliberating the many issues that impact patients,” Ms. Thompson said. “As a patient advocacy organization, we want to ensure that women who are successfully using Avastin today continue to have access to the drug, and that their treatment be covered by third-party payers.”